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Topoisomerase I inhibitors

ctDNA-Guided Therapy for Colorectal Cancer

Phase 1
Recruiting
Led By Farshid Dayyani, MD, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status: ECOG performance status ≤2
Age ≥ 18 years
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug combination to see if it is effective in patients with ctDNA positive colon adenocarcinoma.

Who is the study for?
This trial is for adults with colon adenocarcinoma who have completed at least 3 months of adjuvant chemotherapy and are ctDNA positive. They must be able to swallow tablets, have a life expectancy over 3 months, and an ECOG performance status ≤2. Women of childbearing potential must use contraception.
What is being tested?
The study tests the effectiveness of TAS-102 combined with irinotecan in patients with ctDNA positive colon adenocarcinoma after surgery. It's a phase 1b trial where all participants receive this combination treatment without being randomly assigned to different groups.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding tendencies, liver enzyme changes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My colorectal cancer is at Stage II, III, or IV and I'm eligible for additional chemotherapy after surgery.
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My blood and organ functions are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I haven't had major surgery in the last 4 weeks or chemotherapy/radiotherapy in the last 2 weeks.
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My cancer has spread to other parts of my body.
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I have previously been treated with irinotecan or TAS-102.
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All my side effects from cancer treatment have mostly gone, except for hair loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chemotherapy, Adjuvant
Secondary study objectives
Percentage of Grade 3-5 Adverse Events

Side effects data

From 2019 Phase 3 trial • 507 Patients • NCT02500043
42%
Anaemia
38%
Neutropenia
37%
Nausea
33%
Decreased appetite
26%
Fatigue
24%
Vomiting
22%
Diarrhoea
19%
Asthenia
17%
Leukopenia
15%
Neutrophil count decreased
15%
Abdominal pain
13%
Constipation
10%
Thrombocytopenia
9%
Blood alkaline phosphatase increased
8%
Platelet count decreased
7%
Abdominal pain upper
7%
Pyrexia
7%
White blood cell count decreased
7%
Back pain
6%
Aspartate aminotransferase increased
6%
Lymphopenia
6%
Weight decreased
6%
Dyspnoea
6%
General physical health deterioration
6%
Hypoalbuminaemia
5%
Oedema peripheral
5%
Blood bilirubin increased
5%
Alanine aminotransferase increased
5%
Ascites
4%
Abdominal distension
4%
Dysphagia
4%
Stomatitis
4%
Alopecia
3%
Hypokalaemia
3%
Malaise
3%
Dysgeusia
3%
Cough
3%
Hyperglycaemia
3%
Hypocalcaemia
3%
Hyperbilirubinaemia
3%
Blood creatinine increased
3%
Pleural effusion
3%
Urinary tract infection
3%
Anxiety
3%
Insomnia
2%
Oral candidiasis
2%
Oedema
2%
Arthralgia
2%
Dizziness
2%
Headache
2%
Pancytopenia
2%
Palpitations
2%
Hypomagnesaemia
2%
Blood urea increased
2%
Paraesthesia
2%
Pruritus
2%
Hypotension
2%
Mucosal inflammation
2%
Upper respiratory tract infection
1%
Tumour haemorrhage
1%
Pulmonary embolism
1%
Conjunctivitis
1%
Herpes zoster
1%
Pneumonia
1%
Tonsillitis
1%
Somnolence
1%
Pain
1%
Bronchitis
1%
Fall
1%
Productive cough
1%
Abdominal pain lower
1%
Spinal pain
1%
Oesophageal pain
1%
Protein total decreased
1%
Shock haemorrhagic
1%
Flatulence
1%
Melaena
1%
Enzyme level increased
1%
Cancer pain
1%
Dry skin
1%
Groin pain
1%
Gastrooesophageal reflux disease
1%
Dysphonia
1%
Abdominal discomfort
1%
Tumour pain
1%
Dyspnoea exertional
1%
Odynophagia
1%
Nasopharyngitis
1%
Obstruction gastric
1%
Infection
1%
Septic shock
1%
Jaundice
1%
Acute coronary syndrome
1%
Small intestinal obstruction
1%
Febrile neutropenia
1%
Tachycardia
1%
Dry mouth
1%
Dyspepsia
1%
Haemorrhoidal haemorrhage
1%
Impaired gastric emptying
1%
Rectal haemorrhage
1%
Toothache
1%
Chills
1%
Liver disorder
1%
Respiratory tract infection
1%
Haemoglobin decreased
1%
Hepatic enzyme increased
1%
Lymphocyte count decreased
1%
Cachexia
1%
Dehydration
1%
Hyponatraemia
1%
Musculoskeletal pain
1%
Pain in extremity
1%
Choluria
1%
Urinary retention
1%
Epistaxis
1%
Hiccups
1%
Pneumonia aspiration
1%
Neutropenic sepsis
1%
Haematemesis
1%
Pallor
1%
Vertigo
1%
Cystitis
1%
Decubitus ulcer
1%
Dermatitis
1%
Myocardial infarction
1%
Gastric haemorrhage
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Failure to thrive
1%
Gamma-Glutamyltransferase increased
1%
Bone pain
1%
Myalgia
1%
Lethargy
1%
Neuropathy peripheral
1%
Peripheral sensory neuropathy
1%
Oropharyngeal pain
1%
Nail disorder
1%
Night sweats
1%
Palmar-Plantar erythrodysaesthesia syndrome
1%
Rash
1%
Deep vein thrombosis
1%
Embolism
1%
Hypertension
1%
Metastases to central nervous system
1%
Chest discomfort
1%
Chest pain
1%
Ileus
1%
Intestinal obstruction
1%
Hepatic failure
1%
Lower respiratory tract infection
1%
Rhinitis
1%
Red blood cell count decreased
1%
Muscle atrophy
1%
Agitation
1%
Confusional state
1%
Delirium
1%
Depression
1%
Acute kidney injury
1%
Dysuria
1%
Proteinuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAS-102+BSC
Placebo+BSC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TASIRIExperimental Treatment4 Interventions
Patients randomized to the experimental arm ("TASIRI") will be treated with TAS-102 25mg/m2 p.o. on days 1-5 and irinotecan 180mg/m2 i.v. on day 1 every 14 days. If ANC \<1500/uL on day 1 of a cycle, then G-CSF will be added on day 6 for three days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Treatment
2014
Completed Phase 4
~2720
TAS-102
2019
Completed Phase 3
~2180
Irinotecan
2017
Completed Phase 3
~2590

Find a Location

Who is running the clinical trial?

Natera, Inc.Industry Sponsor
53 Previous Clinical Trials
43,189 Total Patients Enrolled
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,933,026 Total Patients Enrolled
Taiho Pharmaceutical Co., Ltd.Industry Sponsor
65 Previous Clinical Trials
18,211 Total Patients Enrolled
Farshid Dayyani, MD, PhDPrincipal InvestigatorChao Family Comprehensive Cancer Center
3 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Irinotecan (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT04920032 — Phase 1
Colorectal Cancer Research Study Groups: TASIRI
Colorectal Cancer Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT04920032 — Phase 1
Irinotecan (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04920032 — Phase 1
~0 spots leftby Dec 2024
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